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FDA 510(k)

NIHON KOHDEN QP-160AK EEG TREND PROGRAM

K-Number: K092573 · 2010-07-09

ApplicantNihon Kohden America, Inc.
Decision Date2010-07-09
Product CodeOMA
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NIHON KOHDEN QP-160AK EEG TREND PROGRAM is the device name listed in this FDA 510(k) record. The listed applicant is Nihon Kohden America, Inc.. It received FDA 510(k) clearance on 2010-07-09 under 510(k) number K092573. The device is classified under product code OMA. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NIHON KOHDEN QP-160AK EEG TREND PROGRAM?

NIHON KOHDEN QP-160AK EEG TREND PROGRAM is a medical device that received FDA 510(k) clearance on 2010-07-09. The listed applicant is Nihon Kohden America, Inc.. The 510(k) number is K092573.

When did NIHON KOHDEN QP-160AK EEG TREND PROGRAM receive FDA 510(k) clearance?

NIHON KOHDEN QP-160AK EEG TREND PROGRAM received FDA 510(k) clearance on 2010-07-09, under 510(k) number K092573.

Who is the listed applicant for NIHON KOHDEN QP-160AK EEG TREND PROGRAM?

The FDA 510(k) record lists Nihon Kohden America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NIHON KOHDEN QP-160AK EEG TREND PROGRAM?

The FDA product code for NIHON KOHDEN QP-160AK EEG TREND PROGRAM is OMA.

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Other records listing Nihon Kohden America, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K113117NIHON KOHDEN EEG-1200A WITH JE-120A MULTI CHANNEL ELECTRODE JUNCTION BOXK120485NIHON KOHDEN QP-160 AK TREND PROGRAM WITH THE ADDITION OF DSA ASYMMETRY TREND AND FFT PK083456NIHON KOHDEN CO2 SENSOR KIT, MODEL TG-970PK083271BSM-2300 &BSM6000 WITH CGS-9001 SERIES COMMUNICATION GATEWAY, MODEL CGS-9001 SERIES OPTIONAL ACCESSORYK082785NIHON KOHDEN BEDSIDE MONITOR, BSM 9100A SERIESK071969SEN-4100 ELECTRIC STIMULATOR

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Related Devices (Code: OMA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K192889NeoEemagine Medical Imaging Solutions GmbHK163644Nihon Kohden QP-160AK EEG Trend ProgramNihon Kohden CorporationK161027Cadwell AmpliScanCadwell Industries, Inc.K152301Background Pattern Classification [BPc(TM)]Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)K131789CEREBRALOGIK- AEEGMennen Medical , Ltd.K123079OLYMPIC BRAINZ MONITORExcel-Tech Ltd. (Xltek)

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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